NCT03858036

Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Center for Sight, Sacramento, CA · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.

Conditions

• Keratoconus
• Ectasia

Interventions

Type	Name	Description
DRUG	Ricrolin+	1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
DEVICE	VEGA UV-A system	The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.

Timeline

• Start date: 2019-03-08
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-02-28
• Last updated: 2019-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study